LTS Therapy Systems, LLC
Form 483 issued January 31, 2019 · West St. Paul, Minnesota
- Inspection
- Jan 23 – Jan 31, 2019
- Investigators
- Courtney R. Ingalsbe· James K. Ireland
- Observations
- 2
- Pages
- 5
- FEI number
- 2182681
In short: On January 31, 2019, FDA issued a Form 483 with 2 observations to LTS Therapy Systems, LLC in West St. Paul, Minnesota (FEI 2182681) after an inspection that ran Jan 23 – Jan 31, 2019. The investigators were Courtney R. Ingalsbe and James K. Ireland. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×) · 211.182 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written records of major equipment cleaning and maintenance are not included…
This inspection in context
Courtney R. Ingalsbe
4 documents · 2018–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Minnesota.
The firmLTS Therapy Systems, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LTS Therapy Systems, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected LTS Therapy Systems, LLC?
Courtney R. Ingalsbe and James K. Ireland are named on this Form 483, for the inspection of Jan 23 – Jan 31, 2019. Each investigator has a profile showing what they cite most.
When was LTS Therapy Systems, LLC inspected by FDA?
The inspection ran Jan 23 – Jan 31, 2019, and the Form 483 is dated January 31, 2019.
How do I get the full Form 483 for LTS Therapy Systems, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.